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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: F

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with F, grouped by the NDA number the list gives.

FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.

Paragraph IV list captured
17 October 2026
Last checked
30 October 2026

Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.

FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Paragraph IV certificationWhat changed, by week

Famciclovir

NDA 020363 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 125 mg, 250 mg and 500 mg

    RLD/NDA as listed: Famvir 20363
    First PIV submission
    28 Dec 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 May 2020
    First applicant approval
    24 Aug 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2015

Famotidine

NDA 019462 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg and 40 mg

    RLD/NDA as listed: Pepcid 19462
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Famotidine

NDA 020801 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets (Chewable) · 10 mg (OTC)

    RLD/NDA as listed: Pepcid AC (chewable) 20801
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Febuxostat

NDA 021856 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg and 80 mg

    RLD/NDA as listed: Uloric 21856
    First PIV submission
    13 Feb 2013
    ANDAs
    10
    180-day status
    Eligible
    Decision posted
    27 Aug 2019
    First applicant approval
    1 Jul 2019
    First marketing
    1 Jul 2019
    Last qualifying patent expiry (as listed by FDA)
    8 Mar 2024

Fedratinib Hydrochloride

NDA 212327 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 100 mg

    RLD/NDA as listed: Inrebic 212327
    First PIV submission
    16 Aug 2023
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Sep 2039

Felodipine

NDA 019834 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 2.5 mg, 5 mg and 10 mg

    RLD/NDA as listed: Plendil ER 19834
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fenfluramine Hydrochloride

NDA 212102 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 2.2 mg/mL

    RLD/NDA as listed: Fintepla 212102
    First PIV submission
    21 Jun 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2038

Fenofibrate

NDA 019304 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 67 mg, 134 mg and 200 mg

    RLD/NDA as listed: Tricor 19304
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fenofibrate

NDA 021203 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 54 mg, 107 mg and 160 mg

    RLD/NDA as listed: Tricor 21203
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fenofibrate

NDA 021656 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 145 mg

    RLD/NDA as listed: Tricor 21656
    First PIV submission
    19 Oct 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2023

  • Tablets · 48 mg

    RLD/NDA as listed: Tricor 21656
    First PIV submission
    1 Jul 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    5 Apr 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2023

Fenofibrate

NDA 021695 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 43 mg and 130 mg

    RLD/NDA as listed: Antara 21695
    First PIV submission
    15 Sep 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 May 2020
    First applicant approval
    1 Mar 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Aug 2020

Fenofibrate

NDA 022118 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg and 120 mg

    RLD/NDA as listed: Fenoglide 22118
    First PIV submission
    17 Mar 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Dec 2024

Fenofibrate Choline

NDA 022224 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 135 mg

    RLD/NDA as listed: Trilipix 22224
    First PIV submission
    1 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 May 2020
    First applicant approval
    7 Sep 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2025

  • Delayed-release Capsules · 45 mg

    RLD/NDA as listed: Trilipix 22224
    First PIV submission
    2 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 May 2020
    First applicant approval
    7 Sep 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2025

Fentanyl

NDA 019813 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal Extended-release Film · 0.6 mg/24 hr 1.2 mg/ 24 hr 1.8 mg/ 24 hr 2.4 mg/ 24 hr

    RLD/NDA as listed: Duragesic 19813
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fentanyl

NDA 202788 · 2 rows · Listed patents and exclusivities · Open in the app

  • Sublingual Spray · 0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray

    RLD/NDA as listed: Subsys 202788
    First PIV submission
    7 Dec 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    4 Sep 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Apr 2030

  • Sublingual Spray · 0.4 mg/spray

    RLD/NDA as listed: Subsys 202788
    First PIV submission
    22 May 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    4 Sep 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Apr 2030

Fentanyl Citrate

NDA 020747 · 4 rows · Listed patents and exclusivities · Open in the app

  • Lozenges · 0.2 mg

    RLD/NDA as listed: Actiq 20747
    First PIV submission
    29 Oct 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Lozenges · 0.4 mg

    RLD/NDA as listed: Actiq 20747
    First PIV submission
    6 Oct 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Lozenges · 0.6 mg

    RLD/NDA as listed: Actiq 20747
    First PIV submission
    20 Dec 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Lozenges · 0.8 mg, 1.2 mg and 1.6 mg

    RLD/NDA as listed: Actiq 20747
    First PIV submission
    22 Nov 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fentanyl Citrate

NDA 021947 · 1 row · Listed patents and exclusivities · Open in the app

  • Buccal Tablets · 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg

    RLD/NDA as listed: Fentora 21947
    First PIV submission
    13 Nov 2007
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    3/10/2020 3/10/2020
    First applicant approval
    7 Jan 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Mar 2019

Fentanyl Citrate

NDA 022510 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg

    RLD/NDA as listed: Abstral 22510
    First PIV submission
    19 Jun 2014
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    19 May 2020
    First applicant approval
    17 Nov 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Sep 2019

Ferric Carboxymaltose

NDA 203565 · 4 rows · Listed patents and exclusivities · Open in the app

  • Injection · 1 g/20 mL

    RLD/NDA as listed: Injectafer 203565
    First PIV submission
    15 Feb 2022
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    15 Jul 2026
    First applicant approval
    25 Jun 2026
    First marketing
    31 Aug 2026
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2028

  • Injection · 100 mg/2 mL

    RLD/NDA as listed: Injectafer 203565
    First PIV submission
    23 Sep 2022
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    15 Jul 2026
    First applicant approval
    25 Jun 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2028

  • Injection · 500 mg/10 mL

    RLD/NDA as listed: Injectafer 203565
    First PIV submission
    22 Feb 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2028

  • Injection · 750 mg/15 mL

    RLD/NDA as listed: Injectafer 203565
    First PIV submission
    27 Mar 2019
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    15 Jul 2026
    First applicant approval
    25 Jun 2026
    First marketing
    1 Jul 2026
    Last qualifying patent expiry (as listed by FDA)
    15 Feb 2028

Ferric Citrate

NDA 205874 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 210 mg

    RLD/NDA as listed: Auryxia 205874
    First PIV submission
    30 Mar 2015
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    3/2/2026 1/20/2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Apr 2026

Ferumoxytol

NDA 022180 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 30 mg/mL, 17 mL single-use vials

    RLD/NDA as listed: Feraheme 22180
    First PIV submission
    4 Dec 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    9 Feb 2021
    First applicant approval
    15 Jan 2021
    First marketing
    15 Jul 2021
    Last qualifying patent expiry (as listed by FDA)
    30 Jun 2023

Fesoterodine Fumarate

NDA 022030 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 4 mg and 8 mg

    RLD/NDA as listed: Toviaz 22030
    First PIV submission
    31 Oct 2012
    ANDAs
    16
    180-day status
    Eligible
    Decision posted
    19 May 2020
    First applicant approval
    10 Dec 2015
    First marketing
    3 Jul 2022
    Last qualifying patent expiry (as listed by FDA)
    7 Jun 2027

Fexofenadine Hydrochloride

NDA 020625 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 60 mg

    RLD/NDA as listed: Allegra 20625
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fexofenadine Hydrochloride

NDA 020872 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 30 mg, 60 mg and 180 mg

    RLD/NDA as listed: Allegra 20872
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fexofenadine Hydrochloride

NDA 201373 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension (OTC) · 30 mg/5 mL

    RLD/NDA as listed: Allegra 201373
    First PIV submission
    25 Jan 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 Nov 2019
    First applicant approval
    18 Nov 2014
    First marketing
    22 Dec 2014
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2017

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

NDA 020786 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 60 mg/120 mg

    RLD/NDA as listed: Allegra-D 20786
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

NDA 021704 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 180 mg/240 mg

    RLD/NDA as listed: Allegra-D 24 Hour 21704
    First PIV submission
    6 Jun 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 May 2020
    First applicant approval
    22 Jun 2011
    First marketing
    28 Jan 2011
    Last qualifying patent expiry (as listed by FDA)
    25 Dec 2020

Fidaxomicin

NDA 201699 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg

    RLD/NDA as listed: Dificid 201699
    First PIV submission
    27 May 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    22 Jan 2024
    First applicant approval
    16 Jan 2024
    First marketing
    15 Jul 2025
    Last qualifying patent expiry (as listed by FDA)
    31 Jul 2027

Finasteride

NDA 020180 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg

    RLD/NDA as listed: Proscar 20180
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Finasteride

NDA 020788 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg

    RLD/NDA as listed: Propecia 20788
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Finerenone

NDA 215341 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 20 mg

    RLD/NDA as listed: Kerendia 215341
    First PIV submission
    9 Jul 2025
    ANDAs
    9
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jul 2035

  • Tablets · 40 mg

    RLD/NDA as listed: Kerendia 215341
    First PIV submission
    2 Feb 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jul 2035

Fingolimod

NDA 022527 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 0.25 mg

    RLD/NDA as listed: Gilenya 22527
    First PIV submission
    19 Jul 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Nov 2021
    First applicant approval
    12 Nov 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Mar 2032

  • Capsules · 0.5 mg

    RLD/NDA as listed: Gilenya 22527
    First PIV submission
    22 Sep 2014
    ANDAs
    19
    180-day status
    Eligible
    Decision posted
    2 Jan 2020
    First applicant approval
    4 Dec 2019
    First marketing
    21 Sep 2022
    Last qualifying patent expiry (as listed by FDA)
    29 Mar 2026

Flecainide Acetate

NDA 018830 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg and 150 mg

    RLD/NDA as listed: Tambocor 18830
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluconazole

NDA 019949 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg, 150 mg and 200 mg

    RLD/NDA as listed: Diflucan 19949
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluconazole

NDA 020090 · 1 row · Listed patents and exclusivities · Open in the app

  • For Oral Suspension · 50 mg/5 mL and 200 mg/5 mL

    RLD/NDA as listed: Diflucan for Oral Suspension 20090
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Flunisolide

NDA 018148 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Solution · 0.025%

    RLD/NDA as listed: Nasalide 18148
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluocinonide

NDA 016909 · 1 row · Listed patents and exclusivities · Open in the app

  • Ointment · 0.05%

    RLD/NDA as listed: Lidex 16909
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluocinonide

NDA 021758 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 0.1%

    RLD/NDA as listed: Vanos 21758
    First PIV submission
    31 Jan 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    1 Jun 2020
    First applicant approval
    14 Jan 2014
    First marketing
    14 Jan 2014
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2021

Fluorouracil

NDA 020985 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 5.0000000000000001E-3

    RLD/NDA as listed: Carac 20985
    First PIV submission
    29 Jul 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    1 Jun 2020
    First applicant approval
    20 Apr 2015
    First marketing
    1 Nov 2014
    Last qualifying patent expiry (as listed by FDA)
    2 Jun 2021

Fluoxetine Hydrochloride

NDA 018936 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg and 20 mg

    RLD/NDA as listed: Sarafem 18936
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Capsules · 10 mg, 20 mg and 40 mg

    RLD/NDA as listed: Prozac 18936
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluoxetine Hydrochloride

NDA 020101 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 20 mg (base)/5 mL

    RLD/NDA as listed: Prozac 20101
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluoxetine Hydrochloride

NDA 020974 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 20 mg

    RLD/NDA as listed: Prozac 20974
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluoxetine Hydrochloride

NDA 021235 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 90 mg

    RLD/NDA as listed: Prozac Weekly 21235
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Flutamide

NDA 018554 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 125 mg

    RLD/NDA as listed: Eulexin 18554
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fluticasone Furoate

NDA 022051 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 27.5 mcg

    RLD/NDA as listed: Flonase Sensimist Allergy Relief 22051
    First PIV submission
    15 Jul 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Aug 2021

Fluticasone Furoate and Vilanterol Trifenatate

NDA 204275 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Inhalation · 100 mcg/25 mcg

    RLD/NDA as listed: Breo Ellipta 204275
    First PIV submission
    16 Jun 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Oct 2030

Fluticasone Furoate, Umeclidinium Bromide, Vilanterol Trifenatate

NDA 209482 · 2 rows · Listed patents and exclusivities · Open in the app

  • Powder for Inhalation · 100 mcg/62.5 mcg/ 25 mcg

    RLD/NDA as listed: Trelegy Ellipta 209482
    First PIV submission
    26 Nov 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Nov 2030

  • Powder for Inhalation · 200 mcg/62.5 mcg/ 25 mcg

    RLD/NDA as listed: Trelegy Ellipta 209482
    First PIV submission
    19 Mar 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Nov 2030

Fluticasone Propionate

NDA 021152 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 0.05%

    RLD/NDA as listed: Cutivate 21152
    First PIV submission
    28 Jul 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jun 2020
    First applicant approval
    2 May 2011
    First marketing
    26 Mar 2012
    Last qualifying patent expiry (as listed by FDA)
    20 Oct 2019

Fluticasone Propionate

NDA 021433 · 2 rows · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 0.11 mg/inh

    RLD/NDA as listed: Flovent HFA 21433
    First PIV submission
    23 Dec 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Mar 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2026

  • Inhalation Aerosol · 0.22 mg/inh

    RLD/NDA as listed: Flovent HFA 21433
    First PIV submission
    29 Oct 2021
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Mar 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Feb 2026

Fluvastatin

NDA 020261 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg and 40 mg

    RLD/NDA as listed: Lescol 20261
    First PIV submission
    4 Jun 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    11 Apr 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Dec 2011

Fluvastatin Sodium

NDA 021192 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 80 mg

    RLD/NDA as listed: Lescol XL 21192
    First PIV submission
    15 Mar 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Apr 2020

Fluvoxamine Maleate

NDA 022033 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 100 mg

    RLD/NDA as listed: Luvox CR 22033
    First PIV submission
    20 Apr 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    13 Mar 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 May 2020

  • Extended-release Capsules · 150 mg

    RLD/NDA as listed: Luvox CR 22033
    First PIV submission
    13 Apr 2009
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    15 Jun 2020
    First applicant approval
    13 Mar 2013
    First marketing
    13 Mar 2013
    Last qualifying patent expiry (as listed by FDA)
    10 May 2020

Fomepizole

NDA 020696 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1.5 g/1.5 mL

    RLD/NDA as listed: Antizol 20696
    First PIV submission
    14 Apr 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Aug 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Jun 2027

Formoterol Fumarate

NDA 022007 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 0.02 mg/2 mL

    RLD/NDA as listed: Perforomist 22007
    First PIV submission
    21 Jan 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jun 2021

Fosamprenavir Calcium

NDA 021548 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 700 mg

    RLD/NDA as listed: Lexiva 21548
    First PIV submission
    18 Jan 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    20 Nov 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Jul 2019

Fosaprepitant Dimeglumine

NDA 022023 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 115 mg/vial

    RLD/NDA as listed: Emend 22023
    First PIV submission
    25 Jan 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    5 Sep 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Feb 2015

  • Injection · 150 mg/vial

    RLD/NDA as listed: Emend 22023
    First PIV submission
    25 Jan 2012
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Mar 2019

Fosinopril Sodium

NDA 019915 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 20 mg and 40 mg

    RLD/NDA as listed: Monopril 19915
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fosinopril Sodium and Hydrochlorothiazide

NDA 020286 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/12.5 mg and 20 mg/12.5 mg

    RLD/NDA as listed: Monopril HCT 20286
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Fosnetupitant Chloride Hydrochloride and Palonosetron Hydrochloride

NDA 210493 · 1 row · Listed patents and exclusivities · Open in the app

  • Solution in SDV · 235 mg/0.25 mg per 20 mL

    RLD/NDA as listed: Akynzeo 210493
    First PIV submission
    19 Apr 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Jun 2037

Fostamatinib Disodium

NDA 209299 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 150 mg

    RLD/NDA as listed: Tavalisse 209299
    First PIV submission
    18 Apr 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jul 2026
    First applicant approval
    17 Jun 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jul 2032

Frovatriptan Succinate

NDA 021006 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg

    RLD/NDA as listed: Frova 21006
    First PIV submission
    9 Mar 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jun 2020
    First applicant approval
    8 Jul 2014
    First marketing
    29 Apr 2016
    Last qualifying patent expiry (as listed by FDA)
    7 Nov 2015

Fulvestrant

NDA 021344 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 50 mg/mL, 2.5 mL and 5 mL syringe

    RLD/NDA as listed: Faslodex 21344
    First PIV submission
    1 Oct 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    16 Jul 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Jan 2021